Trial · NCT00982397
Safety and Clinical Performance of the Protecta ICD and CRT-D
NCT00982397, Not applicable, Completed, Medtronic Cardiac Rhythm and Heart Failure; results first posted 2017-11-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Clinical Performance of the Protecta ICD and CRT-D. Trials, record NCT00982397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00982397
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Clinical Performance of the Protecta ICD and CRT-D
- NCT number
- NCT00982397
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,770 participants, actual
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Interventions
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- First posted
- 2009-09-23
- Last updated
- 2017-11-06
- Results first posted
- 2017-11-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Who Are Inappropriate Shock Free | Implant to one year post-implant | Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee . |
| Primary | Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I) | Implant to one month post-implant | In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for. |
| Primary | Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off | At implant | In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for. |
| Secondary | Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free | Implant to one year post-implant |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Who Are Inappropriate Shock Free | Implant to one year post-implant | percentage of patients | NUMBER | |
| PRIMARY | Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I) | Implant to one month post-implant | Phase I subjects (a subset of the total number of subjects) implanted with a Protecta device with at least 30 days of follow-up or a USADE within the first 30 days post-implant are included in this analysis. One hundred subjects met the criteria above and are included in the analysis. | percentage of patients | NUMBER |
| PRIMARY | Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off | At implant | Of the 236 subjects implanted, 40 subjects / episodes were classified as not useable. In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free | Implant to one year post-implant | Includes randomized secondary prevention patients from Phase II. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Who Are Inappropriate Shock Free | DR-ICD/CRT-D | 98.5 | 95% Confidence Interval 97.9 to 99.0 | percentage of patients | |
| Percentage of Subjects Who Are Inappropriate Shock Free | VR-ICD | 97.5 | 95% Confidence Interval 96.1 to 98.5 | percentage of patients | |
| Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I) | Phase I | 0 | 95% Confidence Interval NA to 3.0 | percentage of patients | |
| Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off | Phase I | 100 | 97.5% Confidence Interval 98.1 to NA | percentage of patients | |
| Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free | 18/24 NID | 96 | percentage of patients | ||
| Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free | 30/40 NID | 96 | percentage of patients |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I | STARTED | DR-ICD/CRT-D | 236 | |
| Phase I | STARTED | VR-ICD | 0 | |
| Phase I | COMPLETED | DR-ICD/CRT-D | 236 | |
| Phase I | COMPLETED | VR-ICD | 0 | |
| Phase I | NOT COMPLETED | DR-ICD/CRT-D | 0 | |
| Phase I | NOT COMPLETED | VR-ICD | 0 | |
| Phase II/Overall Study | STARTED | DR-ICD/CRT-D | 2,019 | |
| Phase II/Overall Study | STARTED | VR-ICD | 751 | |
| Phase II/Overall Study | Secondary Prevention Randomized 18/24NID | DR-ICD/CRT-D | 231 | |
| Phase II/Overall Study | Secondary Prevention Randomized 18/24NID | VR-ICD | 122 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events622
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | DR-ICD/CRT-D | 8 | 2,019 | |
| serious | Anaemia | Blood and lymphatic system disorders | VR-ICD | 1 | 751 | |
| serious | Anaemia of malignant disease | Blood and lymphatic system disorders | DR-ICD/CRT-D | 1 | 2,019 | |
| serious | Anaemia of malignant disease | Blood and lymphatic system disorders | VR-ICD | 0 | 751 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | DR-ICD/CRT-D | 1 | 2,019 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | VR-ICD | 0 | 751 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | DR-ICD/CRT-D | 1 | 2,019 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | VR-ICD | 0 | 751 | |
| serious | Spontaneous haematoma | Blood and lymphatic system disorders | DR-ICD/CRT-D | 1 | 2,019 | |
| serious | Spontaneous haematoma | Blood and lymphatic system disorders | VR-ICD | 0 | 751 |
1 to 10 of 622Source ClinicalTrials.gov
See all 622 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DR-ICD/CRT-D | ||
| Total, all-cause mortality | VR-ICD | ||
| Total, other adverse events | DR-ICD/CRT-D | 0 | 0 |
| Total, other adverse events | VR-ICD | 0 | 0 |
| Total, serious adverse events | DR-ICD/CRT-D | 452 | 2,019 |
| Total, serious adverse events | VR-ICD | 125 | 751 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| DR-ICD/CRT-D vs VR-ICD: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00982397
GET https://conductscience.org/api/trials/v1/NCT00982397/events?page=2